Comparison · NCT01098032-sae
RenalGuard System Group vs Systemic Alone Therapy Group: serious adverse events
Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.
2 sourcestrial-comparisons-2026-03-23-0.1.0
Cite this record
ConductScience Library. RenalGuard System Group vs Systemic Alone Therapy Group: serious adverse events. Trial comparisons, record NCT01098032-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT01098032-sae
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Measures6
Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.
| Measure | Value | 95% interval, lower | 95% interval, upper | Method | Note |
|---|---|---|---|---|---|
| Risk in group 1 | 0.0685 | 0.0376 | 0.121 | wilson | |
| Risk in group 2 | 0.0959 | 0.058 | 0.155 | wilson | |
| Risk difference, group 1 minus group 2 | -0.0274 | -0.0937 | 0.0378 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 0.714 | 0.328 | 1.56 | log | |
| Odds ratio, group 1 over group 2 | 0.693 | 0.297 | 1.62 | log | |
| Number needed to treat, for one fewer participant with a serious adverse event on RenalGuard System Group than on Systemic Alone Therapy Group | 36.5 | from the risk difference interval | the interval includes no difference |
Source ClinicalTrials.gov
Groups2
Neither group, or both, names a comparator, so the groups keep ClinicalTrials.gov's order.
| Group | Title | Description | With the outcome | Analysed | ClinicalTrials.gov code |
|---|---|---|---|---|---|
| Group 1 | RenalGuard System Group | Prophylactic controlled hydration with saline (0.9%) plus N-acetylcystein (NAC; 6 g in total). In the RenalGuard group, an initial bolus (priming) of 250 ml will be administered. In case of left ventricular dysfunction (ejection fraction ≤30%) and/or unstable hemodynamic conditions the bolus will be reduced to 150 ml. Following the initial bolus, furosemide (0.25 mg/kg) will be administered in order to achieve the optimal urine flow (≥300 ml/h). The hydration will be continued throughout the duration of the procedure and will last 4 hours following the procedure. | 10 | 146 | EG000 |
| Group 2 | Systemic Alone Therapy Group | Systemic alone therapy group was treated by intravenous sodium bicarbonate plus NAC administration. | 14 | 146 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- 1 month
Source ClinicalTrials.gov
Trial
- Title
- RenalGuard System and Contrast Media
- NCT number
- NCT01098032
- Phases
- PHASE3
- Conditions
- Chronic Kidney Disease
- Interventions
- RenalGuard system, Systemic alone therapy
- Lead sponsor
- Clinica Mediterranea
- Results first posted
- 2015-03-10
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT01098032?tab=results
Source ClinicalTrials.gov
Source
- Release
- trial-comparisons-2026-03-23-0.1.0
- Release manifest SHA-256
- f66225897fbf258b57ea10bdacfd0347d3cdfda93f7f5685234b7e06ea36fa57
- AACT copy
- 2026-03-23
- Tables read
- outcome_counts.parquet, outcome_measurements.parquet, outcomes.parquet, reported_event_totals.parquet, reported_events.parquet, result_groups.parquet, studies.parquet, ctgov_trial.parquet
Source ClinicalTrials.gov
Sources 2
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions. The measures are ConductScience's calculation from them.
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